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Medium risk Medical DevicesClass II

Fujirebio Lumipulse pTau 217 Recall

Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse

Updated December 11, 2025

Fujirebio's Lumipulse pTau 217 Plasma Controls (Model 81558) can produce inaccurate test results, potentially causing misclassification of Alzheimer's disease status. The quality control product may yield falsely elevated results, leading to incorrect diagnosis or unnecessary additional testing.

Is the Fujirebio Diagnostics, Inc. recalled? Yes. This product was recalled by FDA on December 11, 2025. Details below.

What is recalled

Lumipulse pTau 217 Plasma Controls, Model/Catalog Number 81558. Two levels available: Level 1 (2 × 1.5 mL) and Level 2 (2 × 1.5 mL). Liquid (frozen) product containing Tris buffer with bovine protein and chemical stabilizers. Preservative: 0.1% ProClin 300, 0.05% ProClin 950. Used with the LUMIPULSE G System for analyzing pTau 217 in K2EDTA plasma.

Am I affected

You are affected if your laboratory uses Lumipulse pTau 217 Plasma Controls Model 81558 as quality control for the LUMIPULSE G System. Check your product catalog number and model number on the packaging.

What to do right now

Contact your laboratory or healthcare provider if you have used this product and have concerns about test result accuracy. The manufacturer has initiated a recall. Consult Fujirebio Diagnostics, Inc. for specific guidance on replacement or corrective measures.

The hazard

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

Brands affected

Fujirebio Diagnostics, Inc.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1304-2026
Classification
Class II
Recalled
December 11, 2025
Read the official notice

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